1. Field of the Invention
This invention relates generally to the field of surgical devices and, more particularly, to a female intraurethral incontinence device which consists of a soft indwelling semi-collapsed catheter for alleviating female urinary incontinence.
2. Discussion of the Prior Art
The female urethra is approximately two inches long. It is situated between the labia and at the entrance of the vaginal tract. It is anatomically difficult or impossible to place an external device on the urethra if the female patient is incontinent. Therefore, incontinent female patients generally employ absorbent devices, such as sanitary towels or pads to compensate for this problem. Recently, suction pads or continence shields have become available in the marketplace. These are essentially suction devices which can be applied externally onto the female urethra in selected patients. One example of this type of device is marketed by Bard Urological Inc., of Georgia under the trade name CAPSURE. Such devices are at best used in highly selected patients, and must be changed many times daily. In addition, it is often difficult to produce an adequate vacuum to hold the device in the proper position onto the user's body for the device to sufficiently function. Another example of this type of device is taught in U.S. Pat. No. 5,813,973. The use of jelly for application of this type of device also tends to irritate the urethra, thus producing urethritis or infection.
An indwelling female catheter will have a broader application, and will not have the problems of changing the device many times every day. In addition, in certain patients dexterity is deficient or limited. In such patient an indwelling female catheter is preferable. Several new devices have recently appeared in the marketplace. The first is marketed by Influence of San Francisco, Calif., while the other female device is marketed by UroQuest Medical Corporation of Sale Lake City, Utah. In both of these devices a metal valve is used. These two catheters must be inserted by the physician, or highly skilled nurse. In addition, the valve is activated by a magnetic device that must be carried by the female patient at all times. Both of these devices are stiff, thus stretching the urethra. This will be uncomfortable for the patient, and may lead to a higher incidence of urinary tract infection. In addition, intercourse is difficult due to the stiffness of the external part of the incontinence device. Intercourse may even dislodge and push the device intraurethrally. This will be very painful, and the patient must report to the nearest hospital for an emergency retrieval of the device. In addition, none of these devices have a safety valve system. If the bladder pressure reaches a dangerously high level, these valves will not open automatically.
It is therefore desirable to have a device that will prevent leakage of the urine. It is also desirable to have a device that the patient can tolerate with minimal or no discomfort. It is also desirable to have an incontinence device with a safety valve that does not open with transient increased intra-abdominal pressure as in coughing, straining, or sneezing, but will open in a continuous high bladder pressure condition. It is also desirable that the device will offer the female patient a normal life including exercise, intercourse, pregnancy and delivery without the smell of urine, or external pads.
The device should have an external padding large enough to prevent the migration into the urethra during strenuous activity, including sexual intercourse. The device should be easily introduced by any nurse, and by the patient after receiving instructions. The device should have a simple valve system that does not need a special tool or device to activate such valve. The valve should also be a safe valve. Safe valves will open spontaneously when the pressure in the bladder reaches a persistently dangerous high level.
The female urethra is always in a state of collapse except during micturition. Continuously stretching the urethra is painful, and can irritate the urethra producing urethritis or urinary tract infection. Therefore the device should be soft, and in a semi-collapsed state. When the valve is open to drain the urine in the bladder, the soft semi-collapsed catheter will stretch slightly to accommodate the flow of urine, thus duplicating the physiological status in the human urethra. A safety valve is used to ensure that a continuously high bladder pressure will not damage the kidneys and produce renal failure.